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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

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SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL Back to Search Results
Model Number 71368569
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 10/23/2020
Event Type  malfunction  
Event Description
It was reported that the handle chipping.Fault in device was found during service pm, therefore, no patient was involved.
 
Manufacturer Narrative
The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The rubberized handle beneath the impact pummel has multiple surface tears.The device was manufactured in 2017 and shows signs of extensive use.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
 
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Brand Name
R3 OFFSET IMPACTOR
Type of Device
PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10849905
MDR Text Key216560268
Report Number1020279-2020-06517
Device Sequence Number1
Product Code JDG
UDI-Device Identifier03596010600240
UDI-Public03596010600240
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number71368569
Device Catalogue Number71368569
Device Lot Number17JM21140
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2020
Initial Date Manufacturer Received 10/23/2020
Initial Date FDA Received11/17/2020
Supplement Dates Manufacturer Received11/17/2020
Supplement Dates FDA Received11/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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